The Relationship Between Total Sialic Acid and Superoxide Dismutase and the Diagnosis and Prognosis of Lipoid Pneumonia

NCT06430008 | Enrolling By Invitation DMC

• 1 other identifier: 2024-KY-144
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to explore the correlation between total sialic acid combined with superoxide dismutase and the diagnosis and prognosis of lipid pneumonia in the patient with lipid pneumonia, cough, bacterial and fungal pneumonia, cryptogenic organizing pneumonia, pulmonary alveolar proteinosis, lung mucinous adenocarcinoma and pulmonary edema. The main question it aims to answer is: Whether superoxide dismutase (SOD) and total sialic acid (TSA) could be used as diagnostic markers to distinguish lipid pneumonia from patient with cough, and bacterial and fungal pneumonia, cryptogenic organizing pneumonia, pulmonary alveolar proteinosis, lung mucinous adenocarcinoma and pulmonary edema, whether SOD and TSA be associated with the prognosis of patients with lipid pneumonia? Participants will answer online survey questions about their symptoms, changes in oxygen status, and changes in the most recent CT image of the lung for up to 10 years after treatment. We will count participants' baseline data including: gender, age, smoking history, comorbidities, lung function, imaging findings, hormone use or not, ICU treatment, death or not, the type of cause of lipid pneumonia, how it is diagnosed, and their baseline SOD and TSA.

Conditions

Lipid Pneumonia; Superoxide Dismutase; Sialic Acid

Outcome Measures

Primary Outcomes (1)

• superoxide dismutase

  At the time of admission

Secondary Outcomes (3)

• sialic acid

  At the time of admission

• death or not

  Within 10 years after discharge

• neutrophil-to-lymphocyte ratio

  At the time of admission

Study Arms (8)

lipid pneumonia

cough

cryptogenic organizing pneumonia

pulmonary alveolar proteinosis

bacterial pneumonia

fungal pneumonia

pulmonary edema

mucinous adenocarcinoma of the lung

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study includes the lipoid pneumonia patients, patients with cough in the upper respiratory tract only, patients with bacterial and fungal pneumonia, patients with cryptogenic organizing pneumonia and pulmonary alveolar proteinosis, patients with lung mucinous adenocarcinoma and patients with pulmonary edema.

You may qualify if:

• Age≥ 18 years old;
• The diagnosis of lipoid pneumonia must be supported by lung biopsy pathological support or positive oil red O or Sudan staining in bronchoalveolar lavage fluid;
• Patients with bacterial and fungal pneumonia must be supported by etiological evidence;
• Patients with cryptogenic organizing pneumonia and pulmonary alveolar proteinosis must be supported by lung biopsy pathology;
• Patients with lung mucinous adenocarcinoma must be supported by lung tissue biopsy;
• Lung imaging of patients with pulmonary edema must show paving stone signs;

You may not qualify if:

• Age\< 18 years old;
• The patient only has a history of lipid inhalation and no pathology or positive lipoid staining;
• Co-infection with the corona virus disease 2019 at the onset of illness;
• Pregnant

Sponsors & Collaborators

• Hu Yinan: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (1)

• Hu Y, Ren Y, Han Y, Li Z, Meng W, Qiang Y, Liu M, Dai H. Relevance of superoxide dismutase type 1 to lipoid pneumonia: the first retrospective case-control study. Respir Res. 2025 Jan 18;26(1):24. doi: 10.1186/s12931-025-03101-3.

  PMID: 39827104 DERIVED

MeSH Terms

Conditions

Pneumonia, Lipid

Condition Hierarchy (Ancestors)

Pneumonia, Aspiration; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yinan Hu

  China-Japan Friendship Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: China-Japan Friendship Hospital

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: May 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)